MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# us157856 lot# 010080 m2a-magnum pf cup 56odx50id.Cat# x11-180317 lot# 817370 bi-metric/x por nc lat 17x165.Cat# 139252 lot# 884510 m2a-magnum 42-50mm tpr insrt-6.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00567.0001825034-2024-00568.0001825034-2024-00570.

Event Description

It was reported that approximately 14 years post implantation of a left total hip arthroplasty, the patient was revised due to pain, and elevated metal ion levels.During the revision surgery, metal related pathology, joint effusion, and osteolysis were noted.The cup and head components were exchanged.There were no surgical complications.No additional information is available.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.H6: component code: mechanical (g04) ¿ head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: patient has started to experience pain in the past few months, intermittently between the right and left side.Evaluation was made including blood work and mri.The patient had elevated cobalt and chromium levels.General anesthesia, ebl 150ml.Incision made along the prior scar, 10ml of brownish colored fluid was aspirated from the joint space and sent for pathology, once the joint space was opened further additional fluid was emerging within the joint.The tissue exhibited changes which are common in metal-on-metal articulation system, all reactive tissue was removed.Bone loss was seen on the posterior portion of the superior femur, that area was debrided to stable bone.The stem was found to be well incorporated in that area, it was evaluated and found to be stable.Bone graft to both sides of the femoral stem.The trunnion was examined and found to be in excellent condition.Osteolysis was found mostly inferiorly at the inferior portion of the acetabulum.The magnum cup was able to be removed with minimal bone loss.Significant bone loss and defects were found mostly anteriorly and towards the pubis bone which had a large cavity towards the marrow cavity.Stability and good rom achieved.Stimulan beads placed deep within joint.Final x-rays were obtained showing all components in ideal position.The patient tolerated the procedure well and went to recovery in stable condition.No complications noted.The event is confirmed via medical records; however, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A-MAGNUM MOD HD SZ 50MM
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18824981
• MDR Text Key: 336738851
• Report Number: 0001825034-2024-00569
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 189170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 07/11/2024
• Supplement Dates FDA Received: 07/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male